This study focuses on the elderly renal deficiency DOR women, to observe the effect of pre-treatment of acupuncture combined with traditional Chinese medicine on the improvement of related indicators in the pregnancy cycle of IVF/ICSI-ET. It will provide clinical research basis for improving ovarian storage function, reducing the risk of POR occurrence of IVF-ET in elderly women, improving the clinical pregnancy rate, and exploring ART combined Chinese and Western medicine methods.

1. Aged between 35 and 42 years old;
2. conforms to the indications for IVF/ICSI-ET;
3. conforms to the diagnostic criteria of DOR;
4. conforms to the diagnostic criteria of renal deficiency syndrome in Chinese medicine;
5. The main causes of infertility are fallopian tube factors, and exclude hypothalamus and other endocrine diseases(hypothyroidism or hyperthyroidism, diabetes, etc.), polycystic ovary syndrome (PCOS), severe pelvic endometriosis, adenomyosis, etc.;
6. Patients agree to participate in this clinical study and sign an informed consent form.

1. Within 3 months, there was a history of steroid hormone treatment and a history of uterine operation;
2. It has been clear that there are obvious and serious other organic lesions in the reproductive organs;
3. With ovarian premature failure, previous ovarian surgery history and only single ovarian;
4. PCOS, adenomyosis, uterine malformations, chromosomal abnormalities, ovarian tumors, and other endocrine diseases(diabetes, thyroid dysfunction, etc.);
5. Hereditary diseases that are not suitable for production, and are currently not capable of being diagnosed by preimplantation genetics under the Maternal and Child Health Act;
6. The couple merged with Severe primary diseases of the cardiovascular, hepatic, renal or hematopoietic systems , or with mental illness;
7. Either of the couple has serious addictions such as drug use and exposure to teratogenic rays, poisons, and drugs and is in the action period;
8. Allergic constitution and allergy to many drugs;
9. Can not insist on treatment.

研究实施时间：

Study execute time：

从From2019-04-01至To 2022-03-31

干预措施：

Interventions：

组别：

暴露组

样本量：

80

Group：

Exposure group

Sample size：

干预措施：

针药结合

干预措施代码：

Intervention：

IVF/ICSI-ET + Acupuncture combined with traditional Chinese medicine

Intervention code：

组别：

对照组

样本量：

80

Group：

Control group

Sample size：

干预措施：

IVF/ICSI-ET

干预措施代码：

Intervention：

IVF/ICSI-ET

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

同济大学附属同济医院

单位级别：

三级甲等

Institution
hospital：

Tongji University Affiliated Tongji Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

优质胚胎率

指标类型：

主要指标

Outcome：

Quality Embryonic Rate

Type：

Primary indicator

指标中文名：

临床妊娠率

指标类型：

次要指标

Outcome：

Clinical pregnancy rate

Type：

Secondary indicator

指标中文名：

获卵数

指标类型：

次要指标

Outcome：

Number of eggs obtained

Type：

Secondary indicator

指标中文名：

证候积分

指标类型：

次要指标

Outcome：

Chinese medicine syndrome integral

Type：

Secondary indicator

指标中文名：

2PN数

指标类型：

次要指标

Outcome：

2PN number,

Type：

Secondary indicator

指标中文名：

卵裂数

指标类型：

次要指标

Outcome：

egg split number

Type：

Secondary indicator

指标中文名：

基础内分泌变化

指标类型：

次要指标

Outcome：

Fundamental endocrine changes

Type：

Secondary indicator

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample：

Destruction after use

Note：

标本中文名：

卵泡液

组织：

Sample Name：

Follicle fluid

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample：

Destruction after use

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Pending

年龄范围：

Participant age：

最小Min age

35

岁years

最大Max age

42

岁years

随机方法（请说明由何人用什么方法产生随机序列）：

非随机

性别：

女性

Randomization Procedure (please state who generates the random number sequence and
by what method)：

Non-random

Gender：

Female

盲法：

Blinding：

试验完成后的统计结果：

Calculated Results ater
the Study Completed：

研究负责(组长)单位：

原始数据公开时间：

The time of sharing IPD：

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

2025年9月30日联系have_time_off@126.com取得

The way of sharing IPD”(include metadata and protocol, If use web-bassed public database, please provide the url)：

Fromhave_time_off@126.com on September 30, 2022

数据保存和管理(说明：数据包括原始记录、病例记录表等数据，采用什么数据库)：

CRF表

The repository and management of the data(Please specify what repository will be used for management of the metadata)：